We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of A3309 in Patients With Dyslipidemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01069783
First Posted: February 17, 2010
Last Update Posted: October 13, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Albireo
  Purpose
The purpose of this trial is to determine the efficacy and safety of A3309 administered to patients with dyslipidemia (high cholesterol levels).

Condition Intervention Phase
Dyslipidemia Drug: A3309 Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase IIa, Double-blind, Randomised, Placebo-controlled, Dose-finding Efficacy and Safety Study of A3309 in Patients With Dyslipidemia

Resource links provided by NLM:


Further study details as provided by Albireo:

Primary Outcome Measures:
  • Change from baseline in low-density lipoprotein (LDL) cholesterol [ Time Frame: eight weeks ]

Enrollment: 36
Study Start Date: February 2010
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A3309 low dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Experimental: A3309 high dose Drug: A3309
A3309 in two different dosage levels
Drug: A3309
A3309 in two different dosage levels for the duration of the study
Placebo Comparator: Placebo Drug: Placebo
Placebo comparator once daily for the duration of the trial

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients meet protocol specified criteria for dyslipidemia and has successfully completed study requirements with no clinically relevant findings

Exclusion Criteria:

  • Medical history or medical condition that would not make the patient a good candidate for the study or would limit the patient´s capability to complete the study
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01069783


Locations
Sweden
BCRC
Linköping, Sweden
Sponsors and Collaborators
Albireo
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Albireo
ClinicalTrials.gov Identifier: NCT01069783     History of Changes
Other Study ID Numbers: A3309-005
First Submitted: February 16, 2010
First Posted: February 17, 2010
Last Update Posted: October 13, 2016
Last Verified: October 2016

Keywords provided by Albireo:
dyslipidemia
cholesterol
LDL

Additional relevant MeSH terms:
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases